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Secures exclusive worldwide license for Nondispersive Infrared (NDIR) laser technology
Launches joint development program for NDIR laser-based diagnostic products to measure glucose, electrolytes and other important biochemical substances through the skin
NEW YORK, Nov. 14, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced the Company and its newly formed subsidiary, Solys Diagnostics Inc. (“Solys”), have entered into definitive license and shareholder agreements with Airware Inc. (“Airware”), and its newly formed subsidiary Liquid Sensing Inc. (“Liquid Sensing”), to develop and commercialize non-invasive diagnostic products using Nondispersive Infrared (NDIR) laser technology developed by laser technology pioneer Dr. Jacob Wong, founder and Chief Executive Officer of Airware.
Dr. Wong’s NDIR laser technology, secured by intellectual property covered under the license agreement, promises to fulfill a decades-long goal of noninvasively measuring glucose, electrolytes and other important biochemical substances in patients, without the need for blood draws, needle sticks or other invasive maneuvers. These technologies have broad applications and large market opportunities in both inpatient settings, where millions of patients undergo frequent blood draws to monitor glucose and other substances, and outpatient settings, where tens of millions of patients use multiple finger sticks daily to manage their diabetes.
“For over fifty years, I have dedicated my professional life to improving the human condition through laser technology,” said Dr. Wong. “Twenty-five years ago, my colleagues and I first sought to tackle the unique challenges of using lasers to detect molecules, including glucose, in liquid and tissues. We have now honed the technology to the point where accurate, commercially viable, noninvasive measurement of blood glucose is around the corner. We are very excited to have found an ideal development and commercialization partner in PAVmed and look forward to being able to offer this technology to patients in the near future.”
“We are proud to partner with Dr. Wong and his team to develop and commercialize revolutionary, non-invasive laser-based diagnostic products, based on proprietary technology and proven results in established scientific models,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “Dr. Wong has been a legend in the field of infrared laser technology since completing his doctorate under Nobel Laureate and Stanford Professor Arthur Schawlow, the co-inventor of the laser. His scientific and commercial impact across multiple industries includes groundbreaking laser-based products for Hughes Aircraft, a predecessor of General Electric Sensing and Hewlett-Packard’s healthcare division.”
“This is PAVmed’s third such partnership with world-class innovators following our licensing of EsoGuard/EsoCheck and DisappEAR,” added Dr. Aklog. “It also falls squarely within our long-term strategy of being opportunistic, but highly selective, in expanding our portfolio with groundbreaking technologies, addressing large unmet clinical needs with low regulatory hurdles, allowing us to access large market opportunities with modest capital investments.
“The partnership provides PAVmed an immediate opportunity to quickly and efficiently develop and commercialize inpatient applications of Dr. Wong’s NDIR technology - most notably a device to noninvasively measure blood glucose using a clip on the hand, just as easily as now-ubiquitous pulse oximetry devices noninvasively measure oxygen saturation levels. Neither the initial joint development work, which is scheduled to take less than six months, nor subsequent regulatory and development work to create a first commercial product, will materially impact our overall budget. Upon completion, I expect several large companies active in the critical care monitoring space to have a strong interest in acquiring or partnering with us on the commercialization of such a product.
“Future inpatient applications within the scope of the license agreement include devices to noninvasively measure electrolytes and other common biochemicals in inpatients, without the need for daily blood draws. Finally, for no additional investment of capital, PAVmed has secured meaningful participation in the future commercial success of outpatient applications of the technology developed by Liquid Sensing, including the holy grail in this field – replacing diabetic finger sticks or continuous needle-based glucose monitoring (CGM) with a portable or wearable non-invasive blood glucose device. PAVmed has also secured an exclusive option to expand its interest in Liquid Sensing at its sole discretion through a right of first offer on future investments,” Dr. Aklog concluded.
Continuous insulin infusions, which typically require hourly blood glucose measurements to optimize control and avoid serious complications, have become a mainstay of modern intensive care. Dr. Marc W. Gerdisch, internationally recognized heart surgeon and Chief of Cardiovascular Surgery at Franciscan St. Francis Health in Indianapolis described the clinical potential of the Solys technology as follows:
“By protocol, one hundred percent of my patients, and the hundreds of thousands of patients who undergo heart surgery each year, are placed on a continuous insulin infusion starting in the operating room and continuing for a period of 24-72 hours during which we check their blood glucose every hour. My patients complain bitterly about being awoken every hour throughout the day and night for finger sticks. A noninvasive device to measure blood glucose would be a gamechanger, a ‘must-have’ technology which would immediately improve the way we care for our patients, while lowering healthcare costs.”
The License Agreement
Pursuant to the license agreement, Airware has assigned Liquid Sensing its entire intellectual property portfolio covering the use of NDIR laser technology to noninvasively measure interstitial concentrations of glucose or other substances through the skin, (the “Licensed Technology”). The portfolio includes seven issued U.S. patents and multiple U.S. and international patent applications, with claims covering the use of NDIR lasers to detect molecules, including glucose, in liquid samples, including blood and interstitial tissue fluid, using proprietary configurations and algorithms to minimize the impact of scattering and interference on accuracy.
Liquid Sensing has, in turn, granted Solys an exclusive perpetual worldwide license to develop and commercialize products based on the Licensed Technology for use in patients receiving care in hospitals or other care facilities (the “Field of Use”).
Pursuant to the agreement, Solys and Liquid Sensing will jointly embark on a rigorous six-month research and development (R&D) program to advance the Licensed Technology to a critical device accuracy milestone, based on established U.S. Food and Drug Administration (FDA) and ISO 15197 standards for blood glucose diagnostic device accuracy. The R&D program will be managed by PAVmed through Solys and will take advantage of PAVmed’s now well-established medical device design control development processes and quality management system.
Once the accuracy milestone is reached, Solys will proceed to develop, seek regulatory clearance for, and commercialize products utilizing the Licensed Technology within the Field of Use. The first product is expected to be a device that non-invasively measures glucose in the intensive care setting. Liquid Sensing will receive customary royalty payments as a percentage of said products’ Net Sales. In parallel, Liquid Sensing will proceed to develop miniaturized, portable and ultimately wearable versions of the device for diabetics in outpatient settings.
Pursuant to shareholder agreements executed concurrently with the license agreement, PAVmed and Airware have agreed to further strengthen their partnership by granting each other 15% non-dilutive equity stakes in their respective subsidiaries, half of these stakes vesting immediately and half vesting upon achievement of the accuracy milestone mentioned earlier. As such, for no additional capital investment, PAVmed will retain a 15% nondilutive equity stake in Liquid Sensing as it seeks to develop wearable glucose monitors, a multi-billion market opportunity that has been an area of keen interest and massive investment by major Silicon Valley technology companies. The shareholder agreements also provide PAVmed with a right of first offer on any future investment in Liquid Sensing, which would permit it to increase its equity stake at its discretion if the value of the company and its portable or wearable noninvasive glucose technology is realized.
PAVmed Inc. is a highly differentiated, multiproduct medical device company employing a unique business model designed to advance innovative products to commercialization much more rapidly and with significantly less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation. PAVmed’s diversified pipeline of products address unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its five lead technologies provide groundbreaking approaches to carpal tunnel syndrome (CarpX™), precancerous conditions of the esophagus (EsoGuard™/EsoCheck™), vascular access (PortIO™), pediatric ear infections (DisappEAR™) and medical infusions (NextFlo™). The company is also developing innovative products in other areas, such as catheters and tissue ablation, while seeking to further expand its pipeline through engagements with clinician innovators and leading academic medical centers. For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn.
This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market any of its products. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Reports on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
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Chief Commercial Officer